A 10-week Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Omega-3 Fatty Acids Oral Capsules Compared With Placebo in the Treatment of Anorexia Nervosa

Further study details as provided by Institute of Psychiatry and Neurology, Warsaw:

Primary Outcome Measures:

Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline [ Time Frame: day 70th ] [ Designated as safety issue: No ]

The primary objective of this study is to compare the efficacy of EPA fatty acids with that of placebo as add-on treatment for inpatients with anorexia nervosa, as assessed by the change from baseline to day 70 in BMI (body mass index)

to evaluate the safety and tolerability of omega-3 fatty acids compared with placebo in the treatment of anorexia nervosa, as assessed by changes from baseline to day 70 in clinical laboratory tests (lipids metabolism - triglycerides, HDL and LDL cholesterol)

10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. Patients will be randomly assigned to blinded study treatment. Double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. Some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. In such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. Patient will be treated as inpatients during 10 weeks of the study. The study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with DSM-IV and ICD-10 diagnosis of anorexia nervosa.BMI below 5 percentile and EAT-26 score > 30 is required at both screening and randomization.

Eligibility

Ages Eligible for Study:

12 Years to 19 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Anorexia nervosa (DSM IV,ICD-10)

Female

Age 12-19

Written informed consent given by patient and his parents

Exclusion Criteria:

Lack of informed consent

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01761942